The Recall Desk
LowFDA (Drugs)·D-0199-2025·Announced 2025-01-22

Diphenhydramine HCl 50 mg Capsules Recalled Due to Incorrect ID Imprinting

Akron Pharma is recalling 324 bottles of Diphenhydramine HCl 50 mg capsules (lot KDC0224001B) due to incorrect identification imprinting on the capsules. The product was distributed nationwide in the United States.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: FDA Class III recall for incorrect ID imprinting on capsules, classified as a labeling/documentation issue without reported illnesses or injuries. Per the severity rubric, documentation issues are classified as Level 1 (Low).

Plain-English summary

Akron Pharma, Inc. is recalling Diphenhydramine HCl 50 mg capsules because the capsules are imprinted with an incorrect identification code. This is an FDA Class III recall.

The recall affects 324 bottles, each containing 1,000 capsules, bearing lot number KDC0224001B with an expiration date of September 30, 2026. The recalled product was distributed nationwide in the United States.

The product is manufactured by Akron Pharma, Inc., located at 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, with National Drug Code (NDC) 71399-8026-02.

The recalled product

Product
Diphenhydramine HCl 50 mg, 1000 capsules per bottle, Akron Pharma, Manufactured for: Akron Pharma, Inc. 373 Route US 46, Building E, Suite 117, Fairfield, NJ 07004, NDC 71399-8026-02.
Manufacturer
Akron Pharma, Inc.
Category
Drug
Hazard
  • wrong-id-imprinting
  • mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: KDC0224001B Exp 09/30/2026

Distribution

Distributed nationwide across the United States.

Related recalls

Same category